tpe sms

THERAPEUTIC PLASMA

EXCHANGE: BOON FOR

NEUROLOGICAL

DISORDER

Department of Immunohaematology & Transfusion Medicine

BLOOD BANK,SMS HOSPITAL, JAIPUR

Introduction



Apheresis – Donor Or Therapeutic

3



• Therapeutic plasma exchange (TPE) is a procedure that reduces circulating autoantibodies in patients. TPE is commonly done in neurological disorders where autoimmunity plays major role.



5

Fundamental Assumption of Therapeutic

Plasma Exchange

Reduce a pathologic substance, antigen: antibody alteration; decrease in

antibody titre; clearance of immune complexes , supply an essential

substance.



Apheresis – Centrifuge (C>>>>M)

6

The Technology



ASFA categories for TPECategory Description

I Disorders for which apheresis is accepted as first-line

therapy, either as a primary standalone treatment or in

conjunction with other modes of treatment.

II Disorders for which apheresis is accepted as second-

line therapy, either as a standalone treatment or in

conjunction with other modes of treatment.

III Optimum role of apheresis therapy is not established.

Decision making should be individualized.

IV Disorders in which published evidence demonstrates or

suggests apheresis to be ineffective or harmful. IRB

approval is desirable if apheresis treatment is undertaken

in these circumstances.



Indications• Neurological disorders

– Acute inflammatory demyelinating polyneuropathy/ Guillain–Barre syndrome

– Myasthenia gravis

– Chronic inflammatory demyelinating polyneuropathy

– Multiple sclerosis

– Neuromyelitis optica

– Acute transverse myelitis

– Acute disseminated encephalomyelitis

• Hematological disorders

– Symptomatic leukocytosis

– Symptomatic thrombocytosis

– Atypical hemolytic uremic syndrome

– Thrombotic thrombocytopenic purpura

– AIHA

• Renal disorders

– ANCA-associated rapidly progressive glomerulonephritis

– Good Pasture’s syndrome

– Post renal transplant rejection (AMR)

– Rapidly progressive glomerulo-nephritis

• Rheumatic disorders

– Systemic lupus erythematosus

• Others

– Wilson’s disease

– ABO incompatible solid organ transplants

– Graft Versus Host disease (GVHD)



Cell Separator

Continuous Vs Intermittent



Vascular Access

• -Peripheral :Anticubital vein using one or two large bore needles (16-18

gauge).

• -Central Venous Access : Catheterize the patient with 12/11.5 no. French dialysis catheter in Internal Jugular, Subclavian, femoral vein

• 60 and 150 mL/minute



Dosage

• Estimated plasma volume(in liters)-0.07 x wt (kg) x(1-Hct)

• 40ml/kg



Replacement Fluids• 0.9% normal saline

• 5% Human albumin (albumin /saline 70%/30%)

• FFP (Group compatible, cross matched)

• The primary function of the replacement fluid is to maintain intravascular volume

- Restoration of important plasma protein

- Maintenance of colloid osmotic pressure

- Maintenance of electrolyte balance



Aims



• We report our experience with regard to indications, adverse events and outcomes of plasma exchange in neurological disorders



Material &

Methods



• 78 procedure were done in ICU settings with HAEMONETICS MCS+ cell separator

• This retrospective study over a period of 1 year from 1st June 2016 to 31st May 2017.

• Detailed Analysis of all the procedures was done by Department of Immunohaematology & Transfusion Medicine,SMS Hospital Jaipur



Results



Age Analysis

• Median age-38 years



0

5

10

15

20

25

30

35

18-27 28-37 38-47 48-57 58-67

Gender Analysis

• Male : Female



0 20 40 60

Male

Female

59

19

Neurological indications

1. Guillain-Barrè syndrome (n = 42)

2. Myasthenia gravis (n = 24)

3. Chronic inflammatory demyelinatingpolyneuropathy (n = 5)

4. Neuromyelitis optica (n = 4)

5. Multifocal motor neuropathy (n = 1)

6. Multiple sclerosis (n = 1)

7. Transverse myelitis (n = 1)



Neurological Indications



0

5

10

15

20

25

30

35

40

45

GBS MG CIDP NMO MMN MS TM

Line Of access

• Central venous access-97 %

• Peripheral venous access-3 %



Central Venous

Peripheral

Replacement Fluid

• Human albumin was used as replacement fluid in 63 %, fresh frozen plasma & normal saline in 100% cases.



0%

20%

40%

60%

80%

100%

Normal SalineFresh Frozen

Plasma Human albumin

Percentage

• Adverse event were recorded in 11 % of the procedures



Advere Event

Uneventful

Adverse event

Adverse Events

• These were mild and manageable such as allergic reactions, hypotension and hypocalcaemia

Hypocalcemia

Allergic reaction

Hypotension6

2 1



Hypocalcemia

Diagnosis SessionsGBS 3

NMO 2

NMO 1



Discussion



• The major indication for the procedure was GBS.

• In GBS, the recommended treatment options are TPE or Intravenous immunoglobulin (IVIG) and both have been found to be equally effective and significantly better than the conservative treatment for recovery from the disability.[1,2,3]

• But in IVIG resistant cases TPE in GBS has shown better outcomes.

1. Hartung HP, Willison HJ, Keiseier BC. Acute immunoinflammatory neuropathy: Update on Guillain-Barresyndrome. Curr Opin Neurol. 2002;15:571–7.

2. van der Meche FG, Schmitz PI. A randomised trial comparing intravenous immunoglobulin and plasma exchange in Guillain-Barre Syndrome. Dutch Guillain Barre Study Group. N Engl J Med. 1992;326:1123–9

3. Randomised Trial of Plasma exchange, Intravenous Immunoglobulin and Combined treatments in GuillainBarre Syndrome. Plasma exchange/Sandoglobulin Guillain-Barre Syndrome Trial Group. Lancet. 1997;349:225–30.



• Because of the ease of administration and less chance of complications, IVIG is preferred by most physicians.

• According to the report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology on plasmapheresis in 2011, it was found that TPE is extremely safe in experienced hands.[4]

4. Cortese I, Chaudhry V, So YT, Cantor F, Cornblath DR, Rae-Grant A. Evidence-based guideline update: Plasmapheresis in neurologic disorders: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2011;76:294–300.]



• Major age group 37-48 with more of male patients.

• Majority of patients were adults and middle aged persons.

• We did not employ TPE in patients in the pediatric age group. The procedures are often performed using evidence or experience extrapolated from adult clinical practice, which may not be evidence based. In addition to the clinical challenges, relevant psychological issues technical hardware are often necessary for safe and effective treatment in children.[5]

5.Wong EC, Balogun RA. Therapeutic apheresis in pediatrics: Technique adjustments, indications and nonindications, a plasma exchange focus. J Clin Apher. 2012;27:132–7.



• Although complication can occur, most of these are rapidly recognized and reversed, and are rarely serious

.• Hypotension, allergic reactions, nausea-vomiting,

paresthesia and arrhythmias are the most common complications of TPE which may be seen in 3-20% of the procedures. These events are usually mild and resolves without treatment.[6]

• Because of problems related to vascular access, 4-5% of PE may have to be terminated.[6]

6. Basic-Jukic N, Brunetta B, Kes P. Plasma exchange in elderly patients. TherApher Dial. 2010;14:161–5.



• We used FFP as the replacement fluid which has been associated with higher incidence of hypotension and other adverse events.

• The French Cooperative Group on plasma exchange in GBS has recommended albumin in place of FFP, as replacement fluid,[7] but we preferred FFP over albumin owing to the higher cost of the latter.

7. Korach JM, Berger P, Giraud C, Le Perff-Desman C, Chillet P. Role of replacement fluids in the immediate complications of plasma exchange. French Registry Cooperative Group. Intensive Care Med. 1998;24:452–8.



• Neurological disorders constitute the leading indication for TPE, followed by hematological, renal and rheumatologic disorders.

• The complication and mortality rates do not vary significantly among different clinical indications.

• The overall mortality rate in TPE, neurological and non-neurological indications combined together, is estimated to be 1-3 per 10,000 procedures.[8]

8. Ward DM. Conventional apheresis therapies: A review. J Clin Apher. 2011;26:230–

8.



Conclusion



• TPE is an effective treatment in neurologic diseases with minimum adverse reaction.

• TPE is not only a safe and effective treatment but also cost effective alternative to IVIG, for various immune mediated neurological disorders



• Always should be done in ICU setting in presence of Transfusion medicine consultant.

• Centrifuge Cell Separator should always be preferred rather than membrane filtration as it is superior in every aspect of quality as well as yield.



THANK YOU



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